May 2009
Blogosphere news (May 26, 2009)
Over the long weekend, I read a lot of blogs that were of interest to me. I thought I’d provide some short analysis and links for those of you who want to read about it. Read More...
The Jenny McCarthy Song
Without making excuses, I really try to keep this blog focused on issues that might impact the medical business world. I am, however, strongly offended by pseudoscience, the primary “authority” for most quack remedies, alternative medicine, and the anti-vaccine movement. I have previously discussed Ms. McCarthy a number of times, and without a doubt, I believe she’s a danger to healthcare. The consequences of the anti-vaccination push is evident by real science. Read More...
The value of blood-glucose monitoring
May/13/09 09:17 Filed in: Medical devices | Healthcare Policy | Medical products | Evidence based medicine
One of the paradigms of managing patients with Type II diabetes includes regular home testing of blood glucose levels using one of the widely available blood glucose monitors. The American Diabetes Association, one of the leading organizations that advocate for and provide information about diabetes, recommends home glucose monitoring for patients who have diabetes and are:
These are probably good recommendations, based on good evidence. Controlling blood glucose in those patients with Type 2 diabetes has strong positive benefits for reducing risks of chronic and acute diseases, such as peripheral artery disease, hypertension, diabetic dyslipidemia, heart attack and stroke.
Recently, a clinical trial published in the British Medical Journal analyzed the medical usefulness of home blood glucose monitoring in patients with Type II diabetes. The trial was well designed enrolling 184 individuals with recently diagnosed type 2 diabetes mellitus. The patients were randomized into two groups: one that utilized a monitor and one that did not. The patients were observed for one year. Read More...
- taking insulin or diabetes pills
- on intensive insulin therapy
- pregnant
- having a hard time controlling your blood glucose levels
- having severe low blood glucose levels or ketones from high blood glucose levels
- having low blood glucose levels without the usual warning signs
These are probably good recommendations, based on good evidence. Controlling blood glucose in those patients with Type 2 diabetes has strong positive benefits for reducing risks of chronic and acute diseases, such as peripheral artery disease, hypertension, diabetic dyslipidemia, heart attack and stroke.
Recently, a clinical trial published in the British Medical Journal analyzed the medical usefulness of home blood glucose monitoring in patients with Type II diabetes. The trial was well designed enrolling 184 individuals with recently diagnosed type 2 diabetes mellitus. The patients were randomized into two groups: one that utilized a monitor and one that did not. The patients were observed for one year. Read More...
Harold Varmus interviewed on C-span
May/11/09 07:59
Yesterday morning, I was listening to Harold Varmus being interviewed live (interspersed with listener calls) on C-SPAN Radio. For those of you unfamiliar with Dr. Varmus, he is currently the co-chair of the President's Council of Advisors on Science and Technology, CEO of Memorial Sloan-Kettering Cancer Center, former Director of the National Institutes of Health (NIH), and a recipient of the Nobel Prize in Physiology or Medicine in 1989. In other words, Dr. Varmus has all of the credentials of a scientists, if not one of the great scientists of our era.
I have been unable to find a transcript of the program, but a couple of points from the interview were particularly memorable to me. First, he made a full-throated support of vaccination of children, and made a diplomatic criticism of the anti-vaccination movement. The second point that stuck with me followed a call from an individual who had one of those “my friend was dying of this, and they went to this website and was cured of that” stories. In this case, the caller said a “friend” of hers was suffering from diabetes (not sure how bad or what type), and her friend went to some website (I was driving, so I didn’t have a chance to write it down) that told her to switch from a high carbohydrate diet to one with lots of proteins and fresh vegetables. Only this diet would “cure” the diabetes. Of course, my thought when I heard this story was, “well, switching to a low carb diet may have been the reason.” Read More...
I have been unable to find a transcript of the program, but a couple of points from the interview were particularly memorable to me. First, he made a full-throated support of vaccination of children, and made a diplomatic criticism of the anti-vaccination movement. The second point that stuck with me followed a call from an individual who had one of those “my friend was dying of this, and they went to this website and was cured of that” stories. In this case, the caller said a “friend” of hers was suffering from diabetes (not sure how bad or what type), and her friend went to some website (I was driving, so I didn’t have a chance to write it down) that told her to switch from a high carbohydrate diet to one with lots of proteins and fresh vegetables. Only this diet would “cure” the diabetes. Of course, my thought when I heard this story was, “well, switching to a low carb diet may have been the reason.” Read More...
Increased FDA scrutiny of medical devices
May/07/09 07:51 Filed in: Medical devices | Medical products
In the early 1990’s, Congress directed the US Food and Drug Administration (FDA) to gather more rigorous evidence before a they give approval to manufacturer to market medical devices that were considered the most risky, a category known as Class III devices. The FDA never implemented the law, and several hundred Class III devices were approved by the FDA based on a less rigorous path using a 510(k), which allows the manufacturer to establish that their products are “substantially equivalent” to products marketed before 1976. Early this year, the Government Accounting Office (GAO) issued a report that stated these conclusions about the process:
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices. Read More...
FDA has stated that eventually all class III devices will require FDA approval through the PMA process and FDA officials reported that the agency is committed to addressing this issue, but the agency has not specified time frames for doing so. Without FDA action, the remaining preamendment class III device types—including device types that FDA identified in 1994 as presenting an unreasonably high risk to public health—may enter the U.S. market through FDA’s less stringent premarket notification process.
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices. Read More...
Point-of-care diagnostics and the flu
I am enamored of the point-of-care (POC) diagnostics market. It is clear that these tests bring benefits to patients, physicians and managed care. Influenza A H1N1 (apparently, the pork industry does is not fond of the swine flu label) may open a huge opportunity for rapid testing for flu.
Quidel Corporation (NASDAQ GS: QDEL) manufactures and markets a rapid (less than 10 minutes from swab to results) diagnostic kit for Influenza A and B (and differentiates between the two). As Quidel states, they are not sure if it detects the swine flu strain. The test should be used for any patients that present with influenza symptoms, because a positive result may rule out other types of infections (and should involve contacting a local health department), although a negative result (if the test does not identify the swine flu type) may not rule out the disease. Read More...
Quidel Corporation (NASDAQ GS: QDEL) manufactures and markets a rapid (less than 10 minutes from swab to results) diagnostic kit for Influenza A and B (and differentiates between the two). As Quidel states, they are not sure if it detects the swine flu strain. The test should be used for any patients that present with influenza symptoms, because a positive result may rule out other types of infections (and should involve contacting a local health department), although a negative result (if the test does not identify the swine flu type) may not rule out the disease. Read More...